Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Study information

Scientific title

Acronym

Study hypothesis

To assess the effectiveness of combined written and oral information, compared with oral information alone on the quality of information before endoscopy and the level of anxiety.

Ethics approval

No ethics approval was required for this trial in 1999. There was no specific ethic committee at the Geneva University Hospital at the time but the trial was approved by the Head of the Division of Gastroenteorlogy.

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Other

Patient information sheet

Condition

Gastrointestinal endoscopy

Intervention

Patients randomized either to receiving, along with the appointment notice, an explanatory leaflet about the upcoming examination, or to oral information delivered by each patient's doctor.

The appointment letter was sent to the patient with or without the written information leaflet within one week before endoscopy for most participants. Patient consent to participate was obtained only upon his arrival for the endoscopic procedure.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Evaluation of quality of information rated on scales between 0 (none received) and 5 (excellent), assessed immediately after the endoscopy

Secondary outcome measures

Patients rated the following, using a questionnaire to be filled within 24 hours and sent back by mail in a prepaid envelope: 1. Their anxiety at the time of the procedure (between none and strong) 2. How tolerable the procedure was (between very easy and very hard) 3. Their pain during the procedure (between none and strong) 4. Whether any health problems occurred as a result of the procedure (none, minor, moderate or severe) 5. The procedure as a whole (between poor and excellent)

Overall trial start date

01/01/1999

Overall trial end date

01/04/1999

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients scheduled for an elective digestive endoscopy (upper gastrointestinal endoscopy or colonoscopy) within three months 2. Resident in Switzerland 3. Understand French language 4. Able to fill in the study questionnaire

Note: Both inpatients and outpatients were included

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

800

Participant exclusion criteria

1. Age <18 years2. Pregnancy3. Patients unable to give their own consent 4. Patients that had already undergone prior endoscopy